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Johnson & Johnson is seeking a Senior Qualification Specialist in Schaffhausen, Switzerland, to lead qualification and computer system validation (CSV) activities for Quality Control laboratories. The role emphasizes data integrity, regulatory compliance, and cross-functional collaboration in a pharmaceutical environment.
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Job Summary
Johnson & Johnson Innovative Medicine is seeking a Senior Qualification Specialist to lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories.
You will drive lifecycle management of analytical instruments and non-analytical utilities, ensuring data integrity and regulatory compliance across systems.
The role involves authoring and revising WIs/SOPs, planning and steering qualification campaigns, and investigating/closing DI/CSV deviations with effective CAPAs.
Matching Summary
Match Score: 75
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Johnson & Johnson is seeking a Senior Qualification Specialist in Schaffhausen, Switzerland, to lead qualification and computer system validation (CSV) activities for Quality Control laboratories. The role emphasizes data integrity, regulatory compliance, and cross-functional collaboration in a pharmaceutical environment.
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Skills & Requirements
Must-have
equipment qualification and re-qualification
Computer System Validation (CSV)
data integrity controls
GMP and site standards
lifecycle management of analytical instruments
Nice-to-have
cross-functional project teams
work-life balance
collaboration with internal partners
support for ongoing development
Key Requirements
MSc or PhD in Natural Sciences, Engineering, Computer Science, or related field
Bachelor’s degree with substantial, relevant GMP experience
Proven experience qualifying laboratory equipment in a GMP environment
Hands-on CSV experience for laboratory/software systems